RESILIENCE Study

Assessment of QBKPN SSI Efficacy in Improving Innate Immune Function in Older Adults (RESILIENCE)

Official Title

Assessment of QBKPN Site-Specific Immunomodulator (SSI) Efficacy in Improving Innate Immune Function and Reducing All-Cause Respiratory Tract Infection Morbidity in Adults 65 Years of Age of Older Residing in Independent-Living, Assisted-Living and Long-term Care Facilities

Study Overview

This is a randomized, double-blind, placebo-controlled study of adults 65 years of age or older residing in the community, in long-term care (LTC), independent-living or assisted-living facilities to assess the effect of QBKPN SSI on improvement of innate immunity and reduction of all-cause respiratory tract infection morbidity.

Approximately 72 participants will be enrolled; approximately 36 from the community and independent-living facilities and approximately 36 from assisted-living and LTC facilities.

Participants will receive study treatment for 4 weeks then be monitored for 22 weeks post-study treatment with follow-up study visits and blood sampling performed.

Immunological testing for trained innate immunity, Natural Killer (NK) cell function, and anti-viral innate immunity will be performed.

Clinical benefits of study treatment will be assessed via medical record review and patient-reported outcomes. Study staff will record any confirmed/probable/possible infections (viral and bacterial, including respiratory and non-respiratory), any microbiologic or radiologic testing performed to investigate for infection, any prescribed antibiotics/antivirals and duration of treatment and reason for and duration of any hospitalizations.

Clinical assessments will also include frailty index (Rockwood Clinical Frailty Scale), quality of life [Dementia Quality of Life Questionnaire(DEMQOL)] and end-of-life prediction score (CHESS Scale.)

Treatment Arms

• QBKPN SSI
• Normal Saline Placebo

Outcome Measures

• Demonstrate innate immune training
• Change in Natural Killer (NK) cell function measured by stimulated Interferon Gamma (IFN-y) production using the NK Vue® assay
• Incidence of treatment-emergent adverse events (safety & tolerability) in participants treated with QBKPN SSI compared to placebo
• Evaluate capacity for anti-viral innate immune response
• Difference in incidence of all-cause respiratory tract infections
• Difference in symptom duration of all-cause respiratory tract infections
• Number of courses of antibiotic/antiviral drugs prescribed
• Difference in incidence of all-cause non-respiratory infection
• Change in quality of life as measured by Dementia Quality of Life (DEMQOL) Scale
• Change in frailty as measured by the Rockwood Clinical Frailty Scale
• Change in end-of-life prediction score as measured by Changes in Health, End-Stage Disease and Signs and Symptoms (CHESS) scale
• Change in all-cause mortality
• Change in additional measures of plasma immune biomarkers that regulate innate & adaptive immune function augmentation

Sponsor 

Qu Biologics Inc.

Additional Funding Provided By

• The National Research Council of Canada Industrial Research Assistance Program

Investigators 

• Principal Investigator: Theodore Steiner, MD FRCPC, University of British Columbia

Posted on ClinicalTrials.gov